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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This problem has resulted in the deaths of 23 people and 60 injuries.

Avanos Mediacal Cortrak 2 This is an item classified as a Class I recall issued by FDA that is the most severe type. Avanos Medical feeding tube These devices can cause serious injuries or even death.

Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system for enteral access. 629 devices, which were distributed between 2016 and 2022, were recalled by the U.S. starting on March 21.

Cortrak*2 assists clinicians in placing medical feeding tubes in the stomachs or small bowels of patients who need to be fed through the tube.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Due to injuries and deaths caused by the system, it was removed. A wrongly placed nasogastric or nasal tube can result in severe injuries or even death.

https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ According to AvanosSafety Communication the number of deaths was 60 and 23 injuries resulting from the issue. There were a variety of adverse events, such as respiratory failure, pneumothorax and perforation as well as pleural effusion and pneumonia.

Cortrak*2 will use this recall to revise the guidelines for use and intended uses. Users will need to confirm the placement of tubes based on established protocols before they can deliver nutrition.

Avanos Mediacal Cortrak 2 Clinicians were requested to attach the correct notice regarding the issue to the operating book, and return the acknowledgement form with the notice to Avanos. Users will soon receive updated labeling and confirmation that the tubes were placed in accordance with the institution's policy.

Avanos Medical
Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015